E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Moderately to Severely Active Crohn's Disease | Enfermedad de Crohn activa de grado moderado o severo | |
E.1.1.1 | Medical condition in easily understood language | Inflammatory bowel disease (IBD) | Enfermedad inflamatoria intestinal | |
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10011401 | E.1.2 | Term | Crohn's disease | E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone) | Evaluar la eficacia de JNJ-78934804 en la semana 48 frente a cada producto en monoterapia (guselkumab solo y golimumab solo) | |
E.2.2 | Secondary objectives of the trial | 1. To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcomes 2. To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo 3. To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo 4. To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy | 1. Evaluar la eficacia de JNJ-78934804 frente a cada producto en monoterapia en cuanto a diversos resultados 2.Evaluar la eficacia de JNJ-78934804 en la semana 24 frente al placebo 3. Evaluar la seguridad de JNJ-78934804 frente a cada producto en monoterapia y frente al placebo 4. Evaluar la farmacocinética (pharmacokinetics, PK) y la inmunogenia de JNJ-78934804 frente a cada producto en monoterapia | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | •Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline •Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD) •Demonstrated inadequate response, loss of response, or intolerance to at least one biologic •If female and of childbearing potential, must meet the contraception and reproduction requirements For an overview of all the inclusion criteria please refer to protocol section 5.1 | - Diagnóstico de enfermedad de Crohn (Crohn's disease, CD) como mínimo 3 meses antes del momento basal - Diagnóstico confirmado de CD moderada o severa, a juzgar por el índice de actividad de la enfermedad de Crohn (Crohn's disease activity index, CDAI), la frecuencia de las deposiciones (stool frequency, SF), la puntuación del dolor abdominal (abdominal pain, AP) y la puntuación endoscópica simple en la enfermedad de Crohn (simple endoscopic score for Crohn's disease, SES-CD) - Evidencia de respuesta insuficiente, pérdida de la respuesta o intolerancia a por lo menos un producto biológico - Cumplimiento de los requisitos relativos a anticoncepción y reproducción en el caso de las mujeres potencialmente fértiles Véase una descripción de todos los criterios de inclusión en la sección 5.1 del protocolo | |
E.4 | Principal exclusion criteria | •Complications of CD that may be anticipated to require surgery •Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery •Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks •Has a draining (example, functioning) stoma or ostomy •Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for greater than or equal to (>=)12 months before the first dose of study intervention •Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer For an overview of all the exclusion criteria please refer to protocol section 5.2 | - Complicaciones de la CD para las que sea previsible que vayan a precisar cirugía - Presencia o sospecha de un absceso actual. No son motivo de exclusión los abscesos recientes que se hayan drenado y tratado adecuadamente por lo menos 3 semanas antes del momento basal, si son cutáneos o perianales, o por lo menos 8 semanas antes del momento basal, si son intraabdominales, siempre que no sea previsible que se vaya a precisar cirugía adicional - Resección intestinal de cualquier tipo en el plazo de las 24 semanas previas, o cualquier otra intervención quirúrgica intraabdominal o mayor de otro tipo en el plazo de las 12 semanas previas - Presencia de estoma u ostomía que drena (por ejemplo, funcional) - Presencia o antecedentes de neoplasia maligna en los 5 años anteriores a la selección, con la excepción del cáncer cutáneo no melanomatoso tratado adecuadamente y sin evidencia de recidiva en un plazo mayor o igual (>=) a 12 meses antes de la primera dosis del tratamiento del estudio - Presencia o antecedentes de enfermedades infecciosas crónicas o recurrentes, tales como, entre otras, de senos paranasales o de vías respiratorias, bronquiectasias, infecciones urinarias recurrentes (por ejemplo, pielonefritis, cistitis), úlcera o herida cutánea abierta, exudativa o infectada Véase una descripción de todos los criterios de exclusión en la sección 5.2 del protocolo | |
E.5 End points |
E.5.1 | Primary end point(s) | Clinical remission and endoscopic response | Remisión clínica y respuesta endoscópica | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | At Week 48 | En la semana 48 | |
E.5.2 | Secondary end point(s) | 1 Patient-Reported Outcomes (PRO)-2 remission and endoscopic remission 2 Clinical remission and endoscopic response of JNJ-78934804 at Week 24 compared with placebo 2 Frequency and type of adverse event (AEs), serious adverse events (SAEs) 3 Serum concentrations of guselkumab and golimumab over time 4 Incidence and titers of antibodies to guselkumab and golimumab 5 Incidence of neutralizing antibodies to guselkumab and golimumab | 1 Remisión según los resultados comunicados por el paciente (Patient-Reported Outcomes, PRO) 2 y remisión endoscópica 2 Remisión clínica y respuesta endoscópica en la semana 24 con JNJ-78934804 en comparación con placebo 2 Frecuencia y tipo de acontecimientos adversos (adverse event, AE) y acontecimientos adversos graves (serious adverse event, SAE) 3 Concentraciones séricas de guselkumab y golimumab a lo largo del tiempo 4 Incidencia y títulos de anticuerpos contra el guselkumab y contra el golimumab 5 Incidencia de anticuerpos neutralizantes contra le guselkumab y contra el golimumab | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | 1 - At Week 48 2 - At Week 24 | 1 - En la semana 48 2 - En la semana 24 | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description | Immunogenicity | Inmunogenia | |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description | Guselkumab and Golimumab (Monotherapy) | |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 125 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | Argentina | Australia | Brazil | Canada | Chile | China | India | Israel | Japan | Jordan | Korea, Republic of | Malaysia | Mexico | New Zealand | Taiwan | United States | Austria | Estonia | Finland | France | Latvia | Lithuania | Poland | Sweden | Bulgaria | Netherlands | Spain | Switzerland | Czechia | Germany | Greece | Italy | Belgium | Bosnia and Herzegovina | Denmark | Georgia | Hungary | Norway | Portugal | Russian Federation | Slovakia | Slovenia | Turkey | Ukraine | United Kingdom | Serbia | |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | The end of study is considered as the last scheduled study assessment shown in the SoA ( Schedule of activities) for the last participant or if a decision has been made by the sponsor not to pursue an indication in CD and appropriate follow-up has been completed. | Se considerará que se ha alcanzado el fin del estudio cuando el último participante se haya sometido a la última evaluación programada del estudio que se muestra en el Calendario de actividades (Schedule of activities, SoA) o si el promotor toma la decisión de no proseguir el desarrollo en la indicación de CD y se ha completado el seguimiento adecuado. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |